More Americans are likely to refuse to get Johnson & Johnson’s Covid-19 vaccine after US health regulators say six women developed a rare blood clotting disorder that left one dead and the other in critical condition, public health and vaccine experts told Tuesday to CNBC.
The Food and Drug Administration on Tuesday asked states to temporarily stop the use of J & J’s one-time vaccination “out of an abundance of caution” after six women aged 18 to 48 of the approximately 6.9 million people who took the vaccine. injection developed septicemia. coagulation disorder known as cerebral sinus vein thrombosis or CVST.
All women developed the condition, which occurs when a blood clot forms in the venous sinuses of the brain, preventing blood from the brain from flowing back to the heart, within about two weeks of receiving the injection, health officials told reporters during a phone call .
“People who have recently received the vaccine within the past few weeks should be aware of any symptoms,” said Dr. Anne Schuchat, the chief deputy director of the Centers for Disease Control and Prevention, at a press conference on Tuesday. “If you have received the vaccine and have developed severe headache, abdominal pain, leg pain, or shortness of breath, you should contact your doctor and seek medical treatment.”
Shortly after the FDA issued the warning, more than a dozen states and some pharmacies took steps to stop J & J vaccinations, with some replacing scheduled appointments with the Pfizer or Moderna vaccines. Some doctors say they are already receiving calls from concerned patients.
People were already skeptical about vaccines before the coronavirus emerged as a new pathogen in China in December 2019, infecting more than 31.2 million Americans and killing at least 562,718 people in just over a year. The warning from US health officials to states is likely to spark even more hesitation in taking J & J’s injection and the other vaccines, threatening to delay the nation’s recovery from the pandemic, health experts told CNBC.
“Unfortunately, it is likely to worsen those who have some degree of hesitation about getting a vaccine,” said Isaac Bogoch, an infectious disease specialist who has served on several drug data and safety oversight committees. “Senior public health officials need to remain open, fair and transparent and above all contextualize that this is low risk.”
According to President Joe Biden’s chief medical advisor, Dr. Anthony Fauci, the goal is to vaccinate between 70% and 85% of the US population – or roughly 232 million to 281 million people – to achieve herd immunity and suppress the pandemic.
According to data from the CDC, more than 120 million Americans, or 36% of the total US population, have received at least one dose of a Covid-19 vaccine to date. About 74 million Americans, or 22% of the total U.S. population, are fully vaccinated, according to the CDC. Children under the age of 16 are not yet allowed to take the photos in the US, and some adults are likely to refuse to receive a vaccine.
“This throws a key to the plans. It will delay the rollout,” said Dr. Jeffrey Kahn, director of the Berman Institute of Bioethics at Johns Hopkins University. ‘People will say,’ I don’t want that one, I want one of the others who doesn’t have that problem, ‘even though it’s an extremely rare event.’
Some Americans, especially in black, Hispanic, and rural communities, were already reluctant to get the J&J vaccine in particular because they considered it inferior to that of Pfizer and Moderna. The J&J injection, which is very effective, especially against serious diseases, showed 72% effectiveness in the US for protection against Covid about a month after the inoculation. This is comparable to the effectiveness of about 95% of the two-dose vaccines of Pfizer and Moderna.
Single-dose vaccines, such as J & J’s, were crucial to “go to communities where a two-dose regimen was not practical or even feasible,” Kahn said. US health officials largely used J & J’s vaccine to reach poorer urban and rural areas where residents could not easily access a vaccine clinic or have reliable Internet access.
“Those communities are also the most affected by Covid,” said Kahn. “Using J&J [is] a blow to do that effectively and quickly. “
Dr. Stephen Schrantz, who was on the team leading a J&J vaccine study at the University of Chicago Medicine, said he already had patients who didn’t want the J&J vaccine, saying the news will give them further evidence to say, “See, I told you.”
“I suspect that the roll-out and uptake of vaccines will slow down, there will be a migration away from the J&J vaccine, even if the CDC and the FDA conclude that there is no causal link,” he said. “And as mask wear diminishes, we may start to see more cases, like we have in Michigan, popping up elsewhere.”
Dr. Scott Gottlieb, who sits on Pfizer’s board of directors, predicted that the move will spark “some people’s reluctance” to get a Covid vaccine.
“Even if there is no causation, even if this is extremely rare, I think we will see the whole conversation being sparked off on social media now,” he told CNBC in an interview.
Dr. Purvi Parikh, an allergy and immunology specialist for infectious diseases at NYU Langone Health, on Tuesday called the FDA a “double-edged sword” warning and said it will likely add concern to the already hesitant Americans. She also said she had already received “panicky calls” from her own patients about the J&J vaccine.
“But if anything, I want to reiterate, this just gives me more confidence in our system because those security checks and balances work. So hopefully it gives some people peace of mind,” she added on “Squawk on the Street. “” Again, to look at the big picture, the benefits still far outweigh the risks of this vaccination. “
Dr. Archana Chatterjee, a pediatric infectious disease specialist and member of the FDA’s Vaccines and Related Biological Products Advisory Committee, echoed Parikh’s comment. She added that there was nothing “unusual” in the way US health regulators are addressing the problem.
“This is a normal procedure that is taking place,” she said.
“But it is clear that whenever serious adverse events are reported about a vaccine that is of concern to the public,” she added. “When you talk about the confidence in vaccines or the reluctance to get vaccinated, could that have an impact? It’s certainly possible.”
Dr. Paul Offit, another member of the Vaccines and Related Biological Products Advisory Committee, said he hopes Americans will think “rationally” about the matter, adding that cases of blood clots appear to be extremely rare. He noted that it could be challenging to convince people in hard-to-reach communities.
“It should be reassuring to people that officials are continuing to search [at the vaccine], even for rare side effects, ”he said.
– CNBC’s Kevin Stankiewicz contributed to this article.